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EXHIBIT NO. 99.1
CONTACTS:
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Sondra Henrichon Wayne Hendry
Director, Investor Relations and Investor Relations
Corporate Communications The Equicom Group, Inc
AltaRex Corp. Toronto, ON Canada
Waltham, MA USA (416)815-0700 ext. 238
(781) 672-0138 ext. 1510 whendry@equicomgroup.com
shenrichon@altarex.com ------------------------
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ALTAREX ANNOUNCES FINANCIAL RESULTS FOR THE FIRST QUARTER 2001
- Highlights Accomplishments Year to Date -
WALTHAM, Mass., May 24 /CNW/ -- AltaRex Corp. (Toronto: AXO, OTC: ALXFF), a
developer of antigen-targeted antibody-based cancer therapeutics, today
announced its financial results for the first quarter ended March 31, 2001. All
dollars reported are Canadian.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
In summary, the Company recorded a net loss of $6.3 million or $0.26 per share
for the three months ended March 31, 2001 compared to a net loss of $3.9
million, or $0.28 per share, for the same period in 2000. The increased net loss
is due primarily to the increased spending in manufacturing and clinical
development for the Company's lead product, OvaRex(R) MAb for ovarian cancer.
The Company is scaling up antibody production under a development and commercial
supply agreement with Abbott Laboratories, while OvaRex(R) MAb is being studied
in six phase II/IIb clinical trials.
At March 31, 2001, the Company's cash and short-term investments totaled $15.2
million as compared to $13.3 million at December 31, 2000. This increase
reflects the sale of 4.4 million common shares for net proceeds of $7.2 million
in February and the net cash burn of the Company from its operations.
The decrease in the net loss per share reflects the impact of an increase in the
weighted average number of shares outstanding from 14,037,786 shares for the
first quarter of 2000 to 24,282,170 shares for the first quarter of 2001. This
increase is due to the issuance of common shares in public offerings in August
2000 and February 2001 and several private placements of common shares related
to corporate partnering collaborations in 2000.
"The Company's tremendous progress year-to-date has us enthusiastically looking
to our most important milestone - the filing of the Company's first Biologics
License Application (BLA) with the U.S. Food and Drug Administration (FDA) for
approval of OvaRex(R) MAb for the treatment of ovarian cancer," said Richard E.
Bagley, President and CEO of AltaRex.
In the first quarter and into the second quarter of 2001, the Company announced
progress in many areas and the successful achievement of a number of important
milestones:
OvaRex(R) Clinical Progress
-- Interim analysis of the lead 345-patient double-blind placebo-
controlled (dbpc) trial, and preliminary results from a 55-patient
dbpc trial provide insight into the importance of CA 125 levels for
patients
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following successful primary therapy. The findings suggest that CA 125
levels are strongly predictive of the course of ovarian cancer. In the
lead trial interim analysis of 252 patients, high risk patients
(elevated CA 125 levels) who received OvaRex(R) MAb experienced a
statistically significant benefit (p.0357) in 6-month disease free
progression versus high risk patients receiving placebo.
-- Results from the 55-patient dbpc trial, now preliminarily reported for
primary analysis, confirm our observation from other OvaRex(R) studies
of a significant correlation between OvaRex(R) induced immune response
(HAMA, Ab2) and clinical benefit as measured by time to disease
relapse.
-- Further, the Company demonstrated in two studies for patients at a
very advanced stage of ovarian cancer (disease is recurrent and/or no
longer responsive to chemotherapy), that even at this late stage,
patients are able to mount a clinically beneficial immune response
induced by OvaRex(R) MAb, without the toxicity associated with
"salvage" chemotherapy.
-- Particularly exciting is the Company's clinical demonstration of
T-cell immune responses; a rare demonstration, we believe, of
drug-activated cytolytic T cell (CTL) and T helper cell responses that
are functional to promote tumor killing.
Scientific Presentations
-- Our clinical and immunology advances have been presented at a number
of key scientific meetings including the Annual Meetings of the
Society of Gynecologic Oncologists (SGO), the American Association for
Cancer Research (AACR), and the American Society of Clinical Oncology
(ASCO), as well as the International Myeloma Workshop, the Cancer
Vaccines Conference, the Keystone Symposium on Dendritic Cells, and
the Helene Harris Memorial Trust Ovarian Cancer Forum in conjunction
with the MD Anderson Cancer Center.
Intellectual Property
-- The Company expanded its intellectual property portfolio by obtaining
an exclusive worldwide license for a family of four U.S. issued
patents and foreign counterparts from the Alberta Research Council,
Inc. These patents extend the Company's vision beyond its current
cancer focus to promising and synergistic therapeutic areas,
specifically autoimmune and inflammatory diseases.
Manufacturing and Quality Assurance
-- The Company entered into an agreement with Abbott Laboratories for
OvaRex(R) MAb antibody manufacturing. The transfer of its proprietary
cell culture manufacturing processes from Lonza Biologics plc to
Abbott allows the Company to leverage the expertise and know-how of
Lonza with
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the scalability of large pharma. The cell culture process is a very
low cost method of manufacturing.
Company Exposure
-- Notable exposure was gained in the investment community with Toronto-
based Yorkton Securities' initiation of analyst coverage of AltaRex
Corp. Analyst David Martin's report titled "Unique Cancer Vaccine
Platform - Near-term Approval Expected" was issued April 30th. Yorkton
Securities rates AltaRex Corp. a TOP PICK.
Clinical data from the lead OvaRex(R) trial, along with five complementary and
supporting trials, will form the basis for a simultaneous filing for OvaRex(R)
MAb approval with both the U.S. and Canadian regulatory authorities. This filing
is anticipated to begin by year end, assuming the timely scale-up of cell
culture manufacturing and the completion of the necessary pharmacokinetic trial
to establish comparability.
Additional information about AltaRex research and development, news and events
can be found on its web site at www.altarex.com. AltaRex Corp. is traded on the
Toronto Stock Exchange under the symbol AXO, and over-the- counter in the United
States under the symbol ALXFF. Clinical information can be found at
www.centerwatch.com. Additional information about ovarian cancer can be found at
www.nci.nih.gov, www.ovarian.org., www.ovariancancer.org and at
www.ovariancanada.org. Additional information about multiple myeloma can be
found at www.multiplemyeloma.org.
This news release contains forward-looking statements that involve risks and
uncertainties, which may cause actual results to differ materially from the
statements made. For this purpose, any statements that are contained herein that
are not statements of historical fact may be deemed to be forward- looking
statements. Without limiting the foregoing, the words "believes," "anticipates,"
"plans," "intends," "expects" and similar expressions are intended to identify
forward-looking statements. Such risks and uncertainties include, but are not
limited to our need for capital and the risk that the Company can not raise
funds on a timely basis on satisfactory terms or at all, changing market
conditions, completion of clinical trials, patient enrollment rates, uncertainty
of pre-clinical, retrospective and early clinical trial results, such as the
results referred to above, which may not be indicative of results that will be
obtained in ongoing or future clinical trials, new corporate alliances, the
establishment of manufacturing processes and the scale up of cell culture
material, the timely development, regulatory approval and market acceptance of
the Company's products, uncertainty as to whether patents will issue from
pending patent applications and, if issued, as to whether such patents will be
sufficiently broad to protect the Company's technology, and other risks detailed
from time-to-time in the Company's filings with the United States Securities and
Exchange Commission and Canadian securities authorities.
THE TORONTO STOCK EXCHANGE HAS NOT APPROVED OR DISAPPROVED OF THE INFORMATION
CONTAINED HEREIN.
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CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In Canadian dollars, unaudited)
Three Months Ended
March 31, March 31,
2001 2000
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REVENUE $ 185,369 $ 91,841
EXPENSES
Research and development 5,069,452 2,434,951
General and administration 1,453,646 1,544,041
6,523,098 3,978,992
Net loss for the period $ (6,337,729) $ (3,887,151)
Net loss per common share $ (0.26) $ (0.28)
Weighted average number of
common shares outstanding 24,282,170 14,037,786
CONDENSED CONSOLIDATED BALANCE SHEET
(In Canadian dollars, unaudited)
As at March 31,
2001 2000
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ASSETS
Cash and cash equivalents $11,480,514 $ 4,728,191
Short-term investments 3,755,052 5,254,327
Other current assets 319,191 124,716
Capital assets, net 497,021 819,299
Other assets 595,855 351,208
$16,647,633 $11,277,741
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 4,792,092 $ 2,399,660
Deferred lease credit -- 39,371
Shareholders' equity 11,855,541 8,838,710
$16,647,633 $11,277,741